German HIV cohort study Nicole Skoetz, Ulrike Bergmann, Sinidu - - PowerPoint PPT Presentation

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German HIV cohort study Nicole Skoetz, Ulrike Bergmann, Sinidu - - PowerPoint PPT Presentation

Sep 14, 2023 244 likes •447 views

German HIV cohort study Nicole Skoetz, Ulrike Bergmann, Sinidu Deneke, Claudia Michalik, Dietmar Theisen, Sven Wiegelmann, Ursula Paulus, Norbert Brockmeyer Content The German HIV cohort study Networking Data set Quality

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SLIDE 1

German HIV cohort study

Nicole Skoetz, Ulrike Bergmann, Sinidu Deneke, Claudia Michalik, Dietmar Theisen, Sven Wiegelmann, Ursula Paulus, Norbert Brockmeyer

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SLIDE 2

Content

  • The German HIV cohort study
  • Networking
  • Data set
  • Quality assurance
  • Summary
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SLIDE 3

The Cohort: Facts

  • Data collection since June 2004
  • 14,200 patients
  • 11,000 follow up 1
  • 7,500 follow up 2
  • 4,000 retrospective data
  • 560 variables
  • Information on blood samples
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SLIDE 4

Networking

  • German HIV cohort study
  • Networking
  • Data set
  • Quality assurance
  • Summary
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SLIDE 5

Networking: project management

KKSK Since 09/2005 Competence network on HIV/AIDS SOP group Data security group Analysis group Future group

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SLIDE 6

Networking: centers

HIV centers paediatrics neurology

  • bstetrics

KKSK Competence network on HIV/AIDS central office

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SLIDE 7

Networking: Data transfer

UMTS Internetzugang

https

Validierter MACRO Laptop zur Datenerfassung

Lokale Erfassung von:

  • IDATs (identifizierende Daten)
  • MDATs (medizinische Daten)

KompNET HIV Pseodonym:

  • Sitecode und lfd.Nr (z.B. koeln01/99)
  • Unidirektionaler

Patientendatentransfer von MDATs vom Laptop zum Server

  • Bidirektionale Kommunikation

mit zentralem Server (z.B. MACRO Laptopadministration)

  • Zentrale KKSK KompNet HIV

Patientendatenbank mit MDATs und KompNet HIV Pseudonym

Firewall 1 Firewall 2 Zertifizierter MACRO Web Server Oracle DB Server

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SLIDE 8

Data set

  • German HIV cohort study
  • Networking
  • Data set
  • Quality assurance
  • Summary
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SLIDE 9

Data set

basic

hepatitis

children neurology exposed pregnancy

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SLIDE 10

Data set: in progress

basic

hepatitis

children neurology exposed pregnancy health economic resistance

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SLIDE 11

Quality assurance

  • German HIV cohort study
  • Networking
  • Data set
  • Quality assurance
  • Summary
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SLIDE 12

SOPs Macro

(InferMed Ltd., London)

plausibility- helpdesk checks Quality assurance

quality

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SLIDE 13

Quality assurance: on-site monitoring

  • n-site

monitoring

according monitoring manual patients‘ concerns informed consent SDV, standardised data entry samples asservation training, support for centers

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SLIDE 14

Quality assurance: dublicates

  • In progress: implementation of TMF‘s data security

concept

  • PID generator
  • Pseudonymisation
  • Electronic data custodian: HIV/TMF-project
  • Until then: PIDs
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SLIDE 15

Quality assurance: feedback to centers

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SLIDE 16
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SLIDE 17
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SLIDE 18

Auswertungen: Öffentlichkeit

  • Online-Auswertungen
  • KompNet Website
  • Doku-Seite individueller

Patient

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SLIDE 19

Summary

  • German HIV cohort study
  • Networking
  • Data set
  • Quality assurance
  • Summary
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SLIDE 20

Summary: the cohort

  • Quality
  • Quantity
  • 15,000 patients
  • Different modules
  • Blood